- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414815
Reverse Prediction of Ion Channel Remodeling in Patients With Atrial Fibrillation Utilizing Monophasic Action Potential and Mathematical Modeling
February 25, 2019 updated by: Yonsei University
Atrial fibrillation(AF) is the most common sustained arrhythmia in humans.
The loss of rate-dependent action potential duration(APD) adaptation is one of the characteristics of atrial fibrillation, but detailed understanding of mechanism is limited.
Thus, we propose to utilize the monophasic action potential recording data from human patients in three groups, control, paroxysmal and persistent atrial fibrillation, and apply reverse engineering method to quantify the extent of electrical remodeling of ionic channel parameters using a mathematical model of atrial cell.
Our approach will be useful in developing drug targets for ion channels in atrial fibrillation patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 120-752
- Severance Cardiovascular Hospital, Yonsei University Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients agreement of consent
- AF patient age 19-75
- Patients who undergoing catheter ablation of atrial fibrillation or supraventricular tachycardia
- Patient agreement of consent who admission for catheter ablation
Exclusion Criteria:
- Patients who do not agree with study inclusion
- Permanent AF refractory to electrical cardioversion
- AF with rheumatic valvular disease
- Patients with left atrial diameter greater than 60mm
- Patients with age less than 19 or more 75
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AF group
Atrial fibrillation
|
After ordinary procedure for electrophysiologic study or catheter ablation, the investigators will replace conventional catheter to monophasic action potential (MAP) recording catheter through right femoral sheath.
MAP recording catheter is introduced to endocardial surface of atrium, and we record atrial MAP at variable pacing cycle lengths: steady state cycle lengths of 600, 400, 300, 240, 220, 240, 260, 300, 400 and 600 ms.
At each cycle length, pacing was applied for 20 sec.
It takes less than 5 min to acquire MAP recordings.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence of AF
Time Frame: One year after the last enrollment
|
The investigators will acquire monophasic action potential from patient's atrium.
Then, we will estimate cardiac ion current status of the patients by reverse engineering and computer simulation.
The patients will be followed up longer than 12 months based on 2012 ACC/AHA/ESC guidelines.
Primary outcomes of the study are AF recurrence and antiarrhythmic drug sensitivity.
Those data will be counted and compared with the patient's own ion current status deducted by simulation study with monophasic action potentials.
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One year after the last enrollment
|
Antiarrhythmic drug sensitivity
Time Frame: One year after the last enrollment
|
The investigators will acquire monophasic action potential from patient's atrium.
Then, we will estimate cardiac ion current status of the patients by reverse engineering and computer simulation.
The patients will be followed up longer than 12 months based on 2012 ACC/AHA/ESC guidelines.
Primary outcomes of the study are AF recurrence and antiarrhythmic drug sensitivity.
Those data will be counted and compared with the patient's own ion current status deducted by simulation study with monophasic action potentials.
|
One year after the last enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 28, 2015
Primary Completion (Actual)
March 2, 2017
Study Completion (Actual)
March 2, 2017
Study Registration Dates
First Submitted
April 3, 2015
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimate)
April 13, 2015
Study Record Updates
Last Update Posted (Actual)
February 27, 2019
Last Update Submitted That Met QC Criteria
February 25, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2014-0685
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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